Biopharmaceutical research is advancing at an impressive pace, offering cutting-edge therapies that are transforming healthcare, altering the natural course of many severe diseases, and significantly improving patients’ quality of life. This progress makes pharmaceutical policy a decisive factor for the efficiency and resilience of the healthcare system, necessitating a structural revision that ensures innovation is timely, sustainable, and equitably accessible- not as a privilege, but as a right for every patient.
The latest EFPIA study on the availability of new medicines across Europe places our country below the average, both in the overall number of new therapies and in the sensitive category of orphan medicines. The main reasons cited for this slow and limited access to innovation are public underfunding and complex approval and reimbursement procedures for new therapies.
The point at which we currently stand is particularly critical. The serious budgetary shortfall and long-standing distortions are leading to a dead end. Official data on the hospital clawback for the first half of 2024, recently announced and once again reaching 80% for the second consecutive year, reflect the magnitude of the problem. This represents an extreme and unjustifiable underfunding of a category of medicines intended for patients with severe, chronic, and rare diseases, administered under fully controlled conditions in the hospital environment, with prices set according to the two lowest in the Eurozone. It puts at real risk patients’ access to essential therapies, destabilizes the pharmaceutical sector, and hinders the introduction of new treatments in our country. It also stands in stark contrast to the Ministry’s intentions for the gradual de-escalation of the issue, highlighting that the measures introduced so far have not delivered the expected results.
The need for a realistic, sustainable, and predictable state budget for medicines is now urgent. The sustainability of the budget can only be ensured through a plan for the gradual increase of resources beyond the horizon of the Recovery & Resilience Facility, through redistribution across distribution channels based on therapeutic needs, as well as through annual adjustment informed by horizon scanning data. The contribution of the industry through rebates must be placed on a realistic, fair, and predictable basis to restore the necessary conditions of stability and predictability.
The digital tools already in place- and those in the pipeline- such as the patient record, e-prescription in hospitals, binding therapeutic protocols, and patient registries, provided they move forward quickly, are implemented universally, and are used in a combined manner, will decisively contribute to the correct allocation of resources according to therapeutic needs, thus freeing up capacity for new therapies.
Nevertheless, timely and equitable access to innovation also requires targeted policies, such as the simplification of evaluation, approval, and reimbursement procedures, including the removal of the 5/11 restriction, particularly within the framework of the new national HTA system being developed in alignment with the European Regulation. For certain categories of innovation, such as orphan medicines, it is also extremely important to ensure rapid and universal access, with provision for a dedicated funding line and consideration of mandatory rebates, in line with the Ministry’s recent announcements. The Innovation Fund currently being designed represents an opportunity in this direction, but according to recent announcements, it appears to have limited capacity relative to the actual needs. At the same time, a comprehensive plan to strengthen clinical trials will immediately ensure free access to new therapies, while generating savings for the system overall.
As the Greek healthcare system is called upon to balance financial sustainability with fair access to innovation, the need for a shared vision and collaborative solutions becomes imperative. In this context, the Voices of Innovation initiative of the PhARMA Innovation Forum unites the voice of the biopharmaceutical community around critical issues such as the value of innovative therapies for patients and their effective support by pharmaceutical policy, the use of data, the attraction of investments, and the support of high-skilled employment. Through dialogue, a strategic, sustainable, and socially fair healthcare model is promoted, in which the role of innovation is recognized as a catalyst for transformation and resilience.
Zefi Vostitsanou, Market Access Director, GENESIS Pharma
